The Vice President, Clinical Affairs will build and lead a diverse and dynamic team responsible for clinical trials/research, clinical operations, clinical data, and clinical engineering. In addition, the Vice President, Clinical Affairs will partner with cross-functional stakeholders in Engineering, Quality, Regulatory, Manufacturing, and other functions to develop systems and procedures to assure uniform operation of all projects in the department. This position is accountable for all Clinical deliverables and reporting.
Leads the group in planning, execution, and interpretation of clinical trials/research
Oversees development, implementation, and maintenance of appropriate standard operating procedures, standard work, and policies to ensure compliance with good clinical practice, global regulations, guidelines, and standards for clinical studies
Establish systems for tracking various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
Collaborates with Regulatory Affairs to strategize best effective approaches to clinical study designs and execution to support regulatory approvals
Manages relationships with vendors and partners as needed for the execution of clinical trials/research
Ensures the proper management and training of all staff and assigned CRO personnel, Associate/ Clinical Research Specialists working on research programs.
Oversees the preparation of final reports, publications, and clinical data presentations for Regulatory submissions, conferences, and study meetings.
Routinely interacts with and reports to executive-level management on the progress of Clinical Affairs programs and studies.
Collaborates with R&D, Program Management, Regulatory Affairs, and Quality Affairs on new product development (NPD) products and processes.
Maintains an effective working relationship with premier scientists in the field, in order to monitor priorities in the field, identify outstanding questions, and review the literature to identify policy questions, or to predict market developments.
Keeps abreast of pertinent literature, prepares and reviews white papers, and provides education to staff as needed.
Monitors developments in the field to assess competitive activity, market developments, and to identify opportunities to broaden service utilization.
Review and communicate clinical needs and potential product enhancements
Advanced Degree in a scientific discipline
A minimum of 10+ years of industry experience (cardiovascular experience a bonus), including at least 4 years of experience specifically in the management of Clinical Affairs staff
A history of building successful clinical teams in a related technical space
Demonstrated proficiency in required software (MS Word, Excel, Outlook, Project, PowerPoint) and computer skills.
Excellent interpersonal skills, strong written and verbal communication/presentation skills necessary to meet the needs of various audiences
Must be able to travel as required for the project
Strong team leadership experience and motivational skills
Able to problem solve and use good judgment
Strong program management skills